STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF OFLOXACIN AND FLAVOXATE HYDROCHLORIDE

  • Mahendra P Rathod P. E. S.’s Modern College of Pharmacy, Nigdi, Pune 411044
  • Shailaja B Jadhav P. E. S.’s Modern College of Pharmacy, Nigdi, Pune 411044
  • Priyanka D Satpute P. E. S.’s Modern College of Pharmacy, Nigdi, Pune 411044

Abstract

Objective: The objective of this study was to develop and validate a stability indicating reverse-phase HPLC method for simultaneous estimation of Ofloxacin and Flavoxate hydrochloride from their combination product.

Methods: The proposed RP-HPLC method was developed using inertsil C18, 5 µm, 250 mm × 4.6 mm column. The mobile phase used was a mixture of methanol and water in the proportion of 50:50 (v/v) with apparent pH adjusted to 4.9, and UV detection at 274 nm using a PDA detector and Empower-2 software. The flow rate was 1.0 ml/min. Ofloxacin, Flavoxate hydrochloride and their combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analysed by the proposed method.

Results: With the optimized method, retention times of Ofloxacin and Flavoxate hydrochloride were found to be 4.3 and 2.98 respectively. Peak homogeneity data of Ofloxacin and Flavoxate hydrochloride peaks obtained using PDA detector, in the stressed sample chromatograms demonstrated the specificity of the method for their estimation in the presence of degradants. The described method was linear over a range of 10-60 µg/ml with regression coefficient of 0.9996 and 0.9998. The mean recoveries were 99.57% and 99.99% for Ofloxacin and Flavoxate hydrochloride, respectively.

Conclusion: Stress testing, which covered acid, alkali, peroxide, photolytic and thermal degradation was performed to prove the specificity of the proposed method and degradation, was achieved. The developed method was validated according to ICH guidelines and was found to be simple, precise and accurate with the prescribed values.

 

Keywords: Ofloxacin, Flavoxate hydrochloride, Stability-indicating method, HPLC

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References

1. Sato K, Inoue Y, Fujii T, Aoyama H, Mitsuhashi S. Antibacterial activity of ofloxacin and its mode of action. Infection 1986;14(4):S226-30.
2. Pedersen E. Studies on the effect and mode of action of flavoxate in human urinary bladder and sphincter. Urol Int 1977;32:202–8.
3. Ali MS. Simultaneous determination of ofloxacin, tetrahydrozoline hydrochloride, and prednisolone acetate by high-performance liquid chromatography. J Chrom Sci 2002;40(8):429-33.
4. Espinosa-Mansilla A. HPLC determination of enoxacin, ciprofloxacin, norfloxacin and ofloxacin with photoinduced fluorimetric (PIF) detection and multi-emission scanning: application to urine and serum. J Chromatogr B: Anal Technol Biomed Life Sci 2005;822:185-93.
5. Fabrea D. A reproducible, simple and sensitive HPLC assay for determination of ofloxacin in plasma and lung tissue: Application in pharmacokinetic studies. J Pharm Biomed Anal 1994;12(11):1463-9.
6. Groeneveld AJN, Brouwers JRBJ. Quantitative determination of ofloxacin, ciprofloxacin, norfloxacin and pefloxacin in serum by high pressure liquid chromatography. Pharm Weekblad 1986;8(1):79-84.
7. Hongyuan Y, Kyung HR. Direct determination of ofloxacin enantiomers in human urine by ligand exchange chromatography. J Liq Chromatogr Relat Technol 2007;30(9):1497–511.
8. Horie M, Saito K, Nose N, Nakazawa H. Simultaneous determination of benofloxacin, danofloxacin, enrofloxacin and ofloxacin in chicken tissue by high-performance liquid chromatography. J Chromatogr B: Biomed Appl 1994;653(1):69-76.
9. Ohkubo T, Kudo M, Sugawara K. Determination of ofloxacin in human serum by high performance liquid chromatography with column switching. J Chromatogr 1992;573(2):289-93.
10. Samanidou VF, Demetriou CE, Papadoyannis IN. Direct determination of four fluoroquinolones, enoxacin, norfloxacin, ofloxacin, & ciprofloxacin, in pharmaceuticals and blood serum by HPLC. Anal Bioanal Chem 2003;375(5):623-9.
11. Hopkala H, Kowalczuk D. Application tablets of derivative UV spectrophotometry for the determination of ciprofloxacin, norfloxacin and ofloxacin in tablets. Acta Pol Pharm 2000;57(1):3-13.
12. Feng, Yu-Lin, Dong, Chuan. Simultaneous determination of trace ofloxacin, ciprofloxacin, and sparfloxacin by micelle TLC–fluorimetry. J Chrom Sci 2004;42(9):474-7.
13. Zheng YJ. Ultra-violet spectrophotometric determination of flavoxate hydrochloride tablets. Yaowu-Fenxi-Zazhi 1993;13:339–40.
14. Wang YT, Wang TL, Zhang J. RP-IP-HPLC determination of flavoxate hydrochloride tablets. Yaowu-Fenxi-Zazhi 2002;22:202–5.
15. El-Gindy A, Abdel-Salam RA, Sallam S. High-performance liquid chromatographic determination of flavoxate hydrochloride and its hydrolysis product. Drug Dev Ind Pharm 2008;34:1311–22.
16. El-Gindy A, Sallam S, Abdel-Salam RA. High performance liquid chromatographic determination of 3-methylflavone-8-carboxylic acid, the main active metabolite of flavoxate hydrochloride in human urine. J Pharm Biomed Anal 2007;44:274–8.
17. Sheu MT, Yeh GC, Ke WT, Ho HO. Development of a high-performance liquid chromatographic method for bioequivalence study of flavoxate tablets. J Chromatogr B Biomed Sci Appl 2001;751:79–86.
18. Ghoneim MM, El-Attar MA, Razeq SA. Voltammetric quantitation at the mercury electrode of the anticholinergic drug flavoxate hydrochloride in bulk and in a pharmaceutical formulation. Central Eur J Chem 2007;5:496–507.
19. Zhang CX, Sun ZP, Ling DK, Zheng JS, Guo J, Li XY. Determination of 3-methylflavone-8-carboxylic acid, the main metabolite of flavoxate, in human urine by capillary electrophoresis with direct injection. J Chromatogr 1993;612:287–94.
20. Yunoos M, Sowjanya M, Pawan Kumar K, Ashok Kumar CH. Stability indicating RP-HPLC method for the simultaneous determination of ofloxacin and flavoxate in bulk and pharmaceutical formulation. J Chem Pharm Res 2014;6(9):381-8.
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Rathod, M. P., S. B. Jadhav, and P. D. Satpute. “STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF OFLOXACIN AND FLAVOXATE HYDROCHLORIDE”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 8, July 2015, pp. 331-5, https://innovareacademics.in/journals/index.php/ijpps/article/view/5939.
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